Room: N-105

221.4 Organ vigilance: Australian perspective (Video Available)

Helen I. Opdam, Australia

National Medical Director
Australian Organ and Tissue Authority


A national vigilance and surveillance system for organ donation and transplantation in Australia is vital to support quality systems in the donation and transplantation sectors; monitor, record and analyse SAERs and the impact of an intervention; improve patient outcomes; and inform future organ donation for transplantation management and health policy.
Australia has implemented a nationally integrated vigilance and surveillance system in organ donation for transplantation in 2017.  The system currently collects limited national information and data on serious adverse events and reactions (SAERs).

The Australian Organ and Tissue Authority (OTA) released the Vigilance and Surveillance Organ, Eye and Tissue Donation and Transplantation Background Paper in 2011 that detailed issues and the need for a national vigilance and surveillance system in Australia.
This background paper led to the development Australian Vigilance and Surveillance Framework for Organ Donation for Transplantation (the Framework). The Framework establishes a central point for reviewing and communicating information pertaining to SAERs in deceased organ donation and transplantation across all the phases of the process; and facilitated retrospective review and analysis of data resulting in reporting to inform clinical practice improvements.
The Framework was completed and received formal approval in September 2016. Furthermore the Framework has been deemed a quality assurance activity by the Australian Commonwealth Minister for Health and as a consequence reporters of events through the national process are protected by Commonwealth Qualified Privilege.

The establishment of a Vigilance and Surveillance Expert Advisory Committee (VSEAC) in 2017 will monitor performance of the vigilance and surveillance system; develop an electronic reporting system; assess SAERs against international reporting criteria; retrospectively analyse SAERs; identify and recommend best practice; identify the potential need for strategic intervention; and provide longer term policy advice.

The primary outcome of the national vigilance and surveillance system is to improve the safety of recipients receiving donor organs in Australia through the ability to identify and mitigate risk, better monitoring, reporting and increasing awareness of SAERs related to organ donation for transplantation.


Learning objectives:

  • Understand the steps undertaken in Australia to implement a national vigilance and surveillance system for monitoring adverse events and reactions associated with organ donation and transplantation.
  • Appreciate the benefits of a vigilance and surveillance system.
  • Development and implementation of a vigilance and surveillance system may be informed by international experience though needs to be tailored to local circumstances and requirements.

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